Clinical Criteria for a Pathogen in Term Newborn Suspected of Neonatal Sepsis

NCT ID: NCT03623503

Last Updated: 2018-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

58 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-21

Study Completion Date

2017-07-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Neonatal early onset sepsis (EOS) diagnosis is difficult due to lack of sensivity and specificity markers. The investigators conduced a restrospectif study to all term born infants born between 1 january and 31 December 2013 and hospitalized for suspect EOS. The presence of neonatal symptoms at birth appears to be a useful clinical marker of probable neonatal EOS.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

neonatal early onset spesis (EOS) remains animportant etiology of neonatal morbidity and mortality. Neonatal early onset sepsis (EOS) diagnosis is difficult due to lack of sensivity and specificity markers. Diagnosis is difficults due to lack of sensivity and specificity markers. The investigators conduced a restrospectif study to all term born infants born between 1 january and 31 December 2013 and hospitalized for suspect EOS.The objective of the study was to identify early clinical signs in newborn infants with suspected neonatal sepsis to differentiate a likely infection with pathogen bacteria in the gastric suction culture.The presence of neonatal symptoms at birth appears to be a useful clinical marker of probable neonatal EOS.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Newborn Sepsis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

first group

Observational study of 25 newborn with a likely EOS

Observational study

Intervention Type OTHER

second group

Observational study of v33 newborn with a possible EOS

Observational study

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Observational study

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Children born at the University Hospital Center in Amiens between 1 January and 31 December 2013 and hospitalized in the neonatology department for suspicion of MFIs

Exclusion Criteria

* Child born before 37 weeks of amenorrhea and / or having a failure in the birth room requiring immediate transfer to neonatal resuscitation or intensive care neonatology
Minimum Eligible Age

1 Day

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pierre Tourneux, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU AMIENS

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RNI2016-18- PrTourneux

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Antibiotic "Dysbiosis" in Preterm Infants
NCT02784821 COMPLETED PHASE2